why-vibativ

Why VIBATIV

VIBATIV is the only FDA-approved, once-daily in vitro bactericidal antibiotic for HABP/VABP or cSSSI due to S. aureus, including MRSA and MSSA.1

VIBATIV reduced the CFU/mL of MRSA within 6 hours

VIBATIV reduced the CFU/mL for MRSA by approximately 5 log-units within 6 hours which was maintained over 24-hours2,3

VIBATIV remains above the MIC90 for MRSA over 24 hours

Plasma concentration remains at least an order of magnitude above the MIC90 for MRSA over the once-daily dosing period1,3

Acts at 2 separate targets on the organism1

Has a prolonged post-antibiotic effect1

Dual mechanism of action: VIBATIV provides potent in vitro bactericidal action with low MICs against multidrug-resistant Gram-positive bacteria, as well as pathogens with reduced susceptibility to vancomycin and daptomycin.1,4,5

An effective treatment when an alternative to vancomycin is required

*S. aureus strains showing a resistant phenotype to methicillin and at least 3 additional classes of antimicrobial agents were defined as multidrug resistant.

VIBATIV has no known pharmacokinetic drug-drug interactions

No clinically significant interactions have been reported with the concomitant use of VIBATIV and other drugs6

VIBATIV is appropriate for patients who need an anti-infective treatment that will not interact with other commonly used medications such as selective serotonin reuptake inhibitors (SSRIs)1

small-icons/dual-moa

Dual Moa

VIBATIV is the only once-daily in vitro bactericidal antibiotic with a dual mechanism of action indicated for infections due to S. aureus, including MRSA and MSSA1

Like vancomycin,
VIBATIV inhibits cell wall synthesis1,7

Unlike vancomycin,
VIBATIV disrupts cell membrane integrity1,7

Watch the MOA video

dosing

Once-daily dosing without therapeutic
drug-level monitoring or a loading dose1

Recommended dosing for VIBATIV: 10 mg/kg administered over a 60-minute period in patients ≥18 years of age by intravenous infusion once every 24 hours

In HABP/VABP, duration of dosing is 7-21 days

In cSSSI, duration of dosing is 7-14 days

The duration of therapy should be guided by the severity of the infection and the patient’s clinical progress

Dosage adjustment for patients with renal impairment1

*Calculate using the Cockcroft-Gault formula and ideal body weight (IBW). Use actual body weight if it is less than IBW.

If renal function decreases, the benefit of continuing VIBATIV versus discontinuing VIBATIV and initiating therapy with an alternative agent should be assessed.

There is insufficient information to make specific dosage adjustment recommendations for patients with end-stage renal disease (CrCl <10 mL/min), including patients undergoing hemodialysis

The following 2 steps can be used to calculate the volume of reconstituted VIBATIV solution required to prepare a dose:

math-eq-aboutVibativ
safety-profile

VIBATIV has an adverse event profile familiar to HCPs1

Total renal adverse events (AEs) in cSSSI studies3*

*Studies include phase 3 ATLAS studies plus a phase 2 study in cSSSI evaluating the safety and efficacy of 10 mg/kg vs vancomycin.

Renal safety considerations

Renal AEs occurred more frequently in the VIBATIV group

AEs occur in patients with risk factors (eg, underlying cardiovascular/renal disease)

  • Rates in patients without risk factors were similar to vancomycin

AEs improved or recovered in the majority of patients in both treatment groups

Monitoring of serum creatinine is recommended in all patients

shield-icon

Safety Information Regarding
Use in Pregnancy

An informational program for healthcare providers has been established to help minimize the risks associated with the use of VIBATIV during pregnancy. The most important relates to the use of the product during pregnancy. Animal data indicate that use of VIBATIV during pregnancy is associated with reduced fetal weight and increased rates of digit and limb malformations in offspring, although these malformations were infrequent.1

Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV.1 Patients should be counseled on the risks and benefits of VIBATIV. Consideration should be given to using an alternative course of therapy if a positive test result is obtained.

The use of VIBATIV should be avoided during pregnancy unless the potential benefit to the patient outweighs the risk to the fetus.1 Women of childbearing potential (those who have not had complete absence of menses for at least 24 months or medically confirmed menopause, medically confirmed primary ovarian failure, a history of hysterectomy, bilateral oophorectomy, or tubal ligation) should use effective contraception during VIBATIV therapy. Patients should be instructed to notify their prescribing physician or healthcare provider if they become pregnant while taking VIBATIV.

A pregnancy registry has been established to collect information about the effects of VIBATIV use during pregnancy. Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the pregnancy registry by calling 1-855-633-8479.

The VIBATIV Medication Guide should be provided to all patients who receive a course of VIBATIV. Please refer to the full Prescribing Information and Medication Guide.

For additional information, please contact Medical Information by calling 1-855-633-8479 or emailing medinfo@theravance.com.

Download a PDF of the letter to healthcare professionals, which also includes important safety information regarding use in pregnancy.

PREGNANCY REGISTRY

To register women exposed to VIBATIV during pregnancy, call 1-855-633-8479

References: 1. VIBATIV® (telavancin) Prescribing Information. Theravance Biopharma Antibiotics, Inc. May 2016. 2. Pace JL, Krause K, Johnston D, et al. In vitro activity of TD-6424 against Staphylococcus aureus. Antimicrob Agents Chemother. 2003;47(11):3602-3604. 3. Data on file. Theravance Biopharma Antibiotics, Inc. 4. Smith JR, Barber KE, Raut A, Rybak MJ. Minimum inhibitory concentrations (MIC) of telavancin (TLV) against methicillin resistant Staphylococcus aureus (MRSA) with reduced susceptibility to daptomycin (DAP), vancomycin (VAN), or linezolid (LZD). 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); September 5-9, 2014; Washington, DC. Poster 2748. 5. Mendes RE, Farrell DJ, Sader HS, Streith JM, Jones RN. Update of the telavancin activity in vitro tested against a worldwide collection of Gram-positive clinical isolates (2013), when applying the revised susceptibility testing method. Diagn Microbiol Infect Dis. 2015;81(4):275-279. 6. Hooper CY, Smith WJ. Telavancin for the treatment of nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus (MRSA). Ther Clin Risk Manag. 2012;8:131-137. 7. Lunde CS, Hartouni SR, Janc JW, Mammen M, Humphrey PP, Benton BM. Telavancin disrupts the functional integrity of the bacterial membrane through targeted interaction with the cell wall precursor lipid II. Antimicrob Agents Chemother. 2009;53(8):3375-3383.

Indication

HABP/VABP

VIBATIV is indicated for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and -resistant isolates). VIBATIV should be reserved for use when alternative treatments are not suitable.

cSSSI

VIBATIV is indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms:

  • Staphylococcus aureus (including methicillin-susceptible and -resistant isolates)
  • Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), or
  • Enterococcus faecalis (vancomycin-susceptible isolates only)

Combination therapy may be clinically indicated if the documented or presumed pathogens include Gram-negative organisms.

Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to telavancin. VIBATIV may be initiated as empiric therapy before results of these tests are known. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VIBATIV and other antibacterial drugs, VIBATIV should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Important Safety Information

Mortality

Patients with pre-existing moderate/severe renal impairment (CrCl ≤50 mL/min) who were treated with VIBATIV for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia had increased mortality observed versus vancomycin. Use of VIBATIV in patients with pre-existing moderate/severe renal impairment (CrCl ≤50 mL/min) should be considered only when the anticipated benefit to the patient outweighs the potential risk.

Nephrotoxicity

New onset or worsening renal impairment occurred in patients who received VIBATIV. Renal adverse events were more likely to occur in patients with baseline comorbidities known to predispose patients to kidney dysfunction and in patients who received concomitant medications known to affect kidney function. Monitor renal function in all patients receiving VIBATIV prior to initiation of treatment, during treatment, and at the end of therapy. If renal function decreases, the benefit of continuing VIBATIV versus discontinuing and initiating therapy with an alternative agent should be assessed.

Fetal Risk

Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV. Avoid use of VIBATIV during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. Adverse developmental outcomes observed in three animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans. If not already pregnant, women of childbearing potential should use effective contraception during VIBATIV treatment.

Contraindication

Intravenous unfractionated heparin sodium is contraindicated with VIBATIV administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after VIBATIV administration.

VIBATIV is contraindicated in patients with a known hypersensitivity to the drug.

Hypersensitivity Reactions

Serious and potentially fatal hypersensitivity reactions, including anaphylactic reactions, may occur after first or subsequent doses. VIBATIV should be used with caution in patients with known hypersensitivity to vancomycin.

Geriatric Use

Telavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group.

Infusion Related Reactions

VIBATIV is a lipoglycopeptide antibacterial agent and should be administered over a period of 60 minutes to reduce the risk of infusion-related reactions. Rapid intravenous infusions of the glycopeptide class of antimicrobial agents can cause “Red-man Syndrome” like reactions including: flushing of the upper body, urticaria, pruritus, or rash.

QTc Prolongation

Caution is warranted when prescribing VIBATIV to patients taking drugs known to prolong the QT interval. In a study involving healthy volunteers, VIBATIV prolonged the QTc interval. Use of VIBATIV should be avoided in patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy.

Most Common Adverse Reactions

The most common adverse reactions (greater than or equal to 10% of patients treated with VIBATIV) were diarrhea, taste disturbance, nausea, vomiting, and foamy urine.

Please see full Prescribing Information including Boxed Warning and Medication Guide.